STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu

From the University of Michigan, Ann Arbor, MI, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Royal Brompton Hospital, London, UK; Scleroderma Research Consultants, LLC, Aiken, SC, USA; EMD Serono Inc., Billerica, MA, USA; University College London Medical School, Royal Free Hospital, London, UK. The STRATUS study was sponsored by Merck KGaA (for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute, Inc., Billerica, MA, USA* (for study sites residing within the USA). Medical writing assistance was provided by Dan Booth (Bioscript Science, Macclesfield, UK) and funded by Merck KGaA. The STRATUS study was funded by Merck KGaA, Darmstadt, Germany and EMD Serono Research Institute Inc. (a business of Merck KGaA, Darmstadt, Germany). Merck KGaA authors were involved in the study design, collection, analysis and interpretation of the data, and in the writing of and decision to submit the manuscript. Address correspondence to Dr Dinesh Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu